CTRI Number |
CTRI/2022/10/046369 [Registered on: 11/10/2022] Trial Registered Prospectively |
Last Modified On: |
10/10/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Medical Device |
Study Design |
Single Arm Study |
Public Title of Study
|
To Evaluate the usefulness of a parameter called perfusion index in predicting the success of ultrasound guided nerve block for surgery |
Scientific Title of Study
|
Evaluation of perfusion index as an early objective tool to predict the success of ultrasound guided costoclavicular block |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Premkumar D |
Designation |
Assistant Professor |
Affiliation |
ESIC Medical College and PGIMSR |
Address |
Department of Anaesthesiology,
First floor,B block,
ESIC medical College and PGIMSR
Chennai TAMIL NADU 600078 India |
Phone |
|
Fax |
|
Email |
d.premkumar.1993@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Premkumar D |
Designation |
Assistant Professor |
Affiliation |
ESIC Medical College and PGIMSR |
Address |
Department of Anaesthesiology,
First floor,B block,
ESIC medical College and PGIMSR
Chennai TAMIL NADU 600078 India |
Phone |
|
Fax |
|
Email |
d.premkumar.1993@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Premkumar D |
Designation |
Assistant Professor |
Affiliation |
ESIC Medical College and PGIMSR |
Address |
Department of Anaesthesiology,
First floor,B block,
ESIC medical College and PGIMSR
Chennai TAMIL NADU 600078 India |
Phone |
|
Fax |
|
Email |
d.premkumar.1993@gmail.com |
|
Source of Monetary or Material Support
|
ESIC Medical college and PGIMSR |
|
Primary Sponsor
|
Name |
Premkumar D |
Address |
Department of Anaesthesiology,
First floor,B block,
ESIC medical College and PGIMSR ,Kk Nagar,Chennai 600037 |
Type of Sponsor |
Other [Self] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Premkumar D |
ESIC Medical College & PGIMSR |
Department of Anaesthesiology,
First floor,B block,
ESIC medical College and PGIMSR,k.k.nagar Chennai TAMIL NADU |
9566220405
d.premkumar.1993@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NIL |
NIL |
Intervention |
Perfusion Index |
Perfusion index will be measured using the monitor Truskan S500. Perfusion Index will be measured using pulse oximetry applied on the index finger. Perfusion Index will be recorded at baseline (before local anaesthetic administration), at every 2 minutes till 10 minutes and then every 5 minutes till 30 minutes.The total duration of the intervention is 30 minutes. |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.American Society of Anaesthesiologist (ASA) class I and II.
2.BMI less than 29.9 Kg/M2.
3.Patients undergoing Upper limb surgeries |
|
ExclusionCriteria |
Details |
1.Patient refusal to regional anaesthesia.
2.Anatomical abnormality at the site
3.Local infection at the site of puncture.
4.Patients having any coagulation abnormality
5.Patient having a known allergy to study drugs
6.Contralateral phrenic nerve palsy
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To test the Predictive accuracy of Perfusion index as an objective tool for the success of costoclavicular block. |
Perfusion index values will be recorded every 2 minutes till 10 mins and then every 5 mins till 30 mins of the block. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the variations in Perfusion index value between successful and unsuccessful block. |
Perfusion index values will be recorded every 2 minutes till 10 mins and then every 5 mins till 30 mins of the block.Data will be recorded for both successful and unsuccessful block , the variations of the perfusion index from the baseline will be measured. |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
17/10/2022 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Brachial plexus block is a popular and widely employed regional nerve block technique for perioperative anaesthesia and analgesia for surgery of the upper extremity. The costoclavicular brachial plexus block (CCB) is a recently introduced infraclavicular approach that targets three cords located lateral to the axillary artery in the costoclavicular space .Cords in this space are located more superficially than with the classical approach at the lateral infraclavicular fossa and are clustered, while maintaining a consistent anatomical relationship with each other In addition, the costoclavicular space is considered a retrograde channel to the supraclavicular area, enabling reliable anaesthesia, including anaesthesia to the suprascapular nerve during shoulder surgery and providing additional stability in catheter placement for a continuous brachial plexus block .Because of these anatomical advantages, the CCB is emerging as a promising infraclavicular approach. Lignocaine 1% and Bupivacaine 0.5% mixture is used frequently for costoclavicular nerve block as it has early onset due to lignocaine and long duration of action due to bupivacaine from 3 to 6 h. The success of the peripheral nerve block is determined by the evaluation of sensory and motor functions. But these conventional methods (Pin-prick test and Modified Bromage Scale) are subjective, and they depend on patient’s cooperation.Many objective methods like laser doppler perfusion imager (LDPI) ,skin electrical resistance, thermographic temperature measurement have been developed to evaluate block success, these are expensive and require special devices Perfusion index (PI) is a simple, objective and noninvasive monitoring modality. It is the ratio of Pulsatile flow to Non pulsatile flow ,Pulsatile flow increases with sympathetic block in the nerve block ,hence perfusion index increases in a successful block .present study aims to evaluate the Change in perfusion index as an early objective tool to predict successful Ultrasonography guided costoclavicular block in patients posted for upper limb surgeries |